22 results · 24ms · Sources: EU EUDAMED, US FDA

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CUBESCAN / BIOCON-700

FDA 510(k)
FDA Class 2 ·Radiology

ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·August 29, 2012

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089423880·

MicroSelectron Digital

FDA UDI
Nucletron B.V.·08717213015043·microSelectron Transfer Tube Set for Metal Need...

MABIS

FDA UDI
D-M-S HOLDINGS, INC.·00767056111219·LATEX-FREE LEGACY ANEROID SPHYG W/NYLON CUFF BL...

BD PLASTIPAK¿ SYRINGES

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·January 28, 2023

BD PLASTIPAK¿ SYRINGES

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·January 28, 2023

SETx TLIF TAMP

FDA UDI
XENCO MEDICAL LLC·B064XMPH11110211·

DASH HIP

FDA 510(k)
FDA Class 2 ·Neurology

LASER 20

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

JDEVOLUTION PLUS

FDA Adverse Event
Injury ·J DENTAL CARE SRL·Product code DZE·August 6, 2025

NEOPUFF INFANT RESUSCITATOR

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·January 15, 2013

UNKNOWN DEPUY ACETABULAR CUP

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·May 14, 2013

AMIS BROACH HANDLE

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL, SA·Product code JDI·May 5, 2011

CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code KRH·August 12, 2008

MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.

FDA Enforcement
Class II ·Terminated·Ecolab Inc·February 19, 2014

MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

FDA Enforcement
Class II ·Terminated·Ecolab Inc·February 19, 2014

5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover

FDA Enforcement
Class II ·Terminated·Custom Medical Specialties, Inc.·February 19, 2014

ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

FDA Enforcement
Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

FDA Enforcement
Class II ·Ongoing·Medtronic Neurosurgery·July 26, 2023